| Nr. | Title |
| |
| 783 | Guideline on Summary of Product Characteristics (September 2009) |
| 784 | Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products |
| 785 | Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure |
| 787 | Guideline on the packaging information of medicinal products for human use authorised by the Community (February 2008) |
| 788 | Guideline on changing the classification for the supply of a medicinal product for human use |
| 789 | Guideline on the readability of the label and package leaflet of medicinal product for human use, revision 1 (12 January 2009) |
| 795 | Q10 Pharmaceutical Quality System |
| 832 | 91/412/EEC - Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products |
| 835 | Chapter 1: Pharmaceutical Quality System |
| 836 | Chapter 2: Personnel |
| 837 | Chapter 3: Premises and Equipment |
| 839 | Chapter 5: Production |
| 840 | Chapter 6: Quality Control |
| 841 | Chapter 7: Outsourced Activities |
| 842 | Chapter 8: Complaints and Product Recall |
| 843 | Chapter 9: Self Inspection |
| 857 | Annex 13: Investigational Medicinal Products |
| 859 | Annex 14: Manufacture of Medicinal Products derived from Human Blood or Plasma |
| 864 | Glossary |
| 870 | DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices |
| 875 | Q1B Stability Testing: Photostability Testing of New Drug Substances and Products |
| 876 | Q1C Stability Testing: Requirements for New Dosage Forms |
| 879 | Q2(R1) Validation of Analytical Procedures: Text and Methodology |
| 885 | Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin |
| 886 | Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
| 887 | Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products |
| 888 | Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products |
| 892 | M4Q(R1) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - Quality Overall Summary of Module 2 - Module 3: Quality |
| 893 | M4(R3) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use |
| 918 | Mutual Recognition Agreement Between the European Community and the United States of America Mai 1998 |
| 919 | Joint Procedure for the Information Exchange of Serious or Life-Threatening Human / Animal Pharmaceutical Product Quality Defects and Recalls May 2001 |
| 926 | Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007 |
| 929 | PIC/S GMP Guide for Blood Establishments (PE 005-3) Sept 2007 |
| 932 | Isolators used for Aseptic Processing and Sterility Testing (PI 014-3) Sept 2007 |
| 1090 | The IPEC Excipient Composition Guide |
| 1100 | Process Simulation Testing for Aseptically Filled Products |
| 1101 | GAMP Good Practice Guide: a Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5 |
| 1162 | A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry |
| 1167 | GAMP-Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacturing, Version 5.0 |
| 1202 | Aide-Memoire - Inspection of Utilities (PI 009-3) Sept 2007 |
| 1203 | SOP - Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-4) Jan 2011 |
| 1204 | Standard Operating Procedure - PIC/S Inspection Report Format (PI 013-3) Sept 2007 |
| 1235 | Guidance for Industry - Cybersecurity for Networked Medical Devices Containing off-the-Shelf (OTS) Software |
| 1238 | Changes to an Approved NDA or ANDA, Questions and Answers |
| 1241 | EC-Swiss, Explanatory Notes to Chapter 15 (Medicinal Products GMP inspection and batch certification) of Annex 1 of the EU-Swiss MRA October 2002 |
| 1244 | EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES
(GMP) |
| 1245 | EC-Australia MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification |
| 1246 | EC-New Zealand MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification |
| 1263 | Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed |
| 1264 | Q1E Evaluation of Stability Data |
| 1266 | Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products |
| 1267 | Q3A(R2) Impurities in New Drug Substances |
| 1268 | Q3C(R5) Impurities: Guideline for residual solvents |
| 1270 | Q6A Attachments: Decision Trees #1 Through #8 |
| 1272 | Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols |
| 1275 | Guide to Inspections of Quality Systems |
| 1276 | Medical Device Tracking |
| 1277 | Guideline for the Manufacture of In Vitro Diagnostic Products |
| 1278 | Guideline for the Monitoring of Clinical Investigations |
| 1279 | Quality System Information for Certain Premarket Application Reviews, Guidance for Industry |
| 1282 | Labelling - Regulatory Requirments for Medical Devices |
| 1283 | Medical Glove Guidance Manual |
| 1284 | GUIDANCE ON PARAMETRIC RELEASE (PI 005-2) July 2004 |
| 1286 | 89/105/EEC - Council Directive 89/105/EEC of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems - English Version |
| 1288 | EC/297/95 - Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products.
Amended by Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products.
Amendments |
| 1289 | EC/540/95 - Commission Regulation (EC) No 540/95, of 10 March 1995, laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93. |
| 1290 | Corrigendum (Official Journal L 230, 24/8/2006 p. 12 PL). |
| 1292 | EC/1662/95 - Commission Regulation (EC) No 1662/95, of 7 July 1995, laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use. |
| 1293 | EC/2141/96 - Commission Regulation (EC) No 2141/96, of 7 November 1996, concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93. |
| 1294 | EC/141/2000 - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. |
| 1295 | EC/847/2000 Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and‘clinical superiority’ |
| 1297 | Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices |
| 1302 | 6/5/1982 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted. |
| 1303 | 94/C 82/04 Commission Communication on the implementation of the new marketing authorization procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC, adopted on 14 June 1993. |
| 1304 | 98/C 229/03 Commission communication on the Community marketing authorisation procedures for medicinal products |
| 1305 | 75/320/EEC - Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee. |
| 1312 | COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS |
| 1314 | Comparison Chart GMP/ISO 9000:1994 |
| 1315 | Guidance on IDE Policies and Procedures |
| 1317 | Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers |
| 1318 | Determination of Intended Use for 510(k) Devices; Guidance for
CDRH Staff (Update to K98-1) |
| 1320 | Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices |
| 1321 | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| 1324 | Labelling For Medical Devices |
| 1326 | Q1C Stability Testing for New Dosage Forms |
| 1327 | Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products |
| 1332 | Charge & Mission Statement |
| 1336 | Process Validation Guidance |
| 1337 | Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7) |
| 1338 | Guidelines for Regulatory Auditing of Quality Systems
of Medical Device Manufacturers –Part 1: General Requirements |
| 1339 | Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies |
| 1343 | 21 CFR Part 314.420 Drug Master Files |
| 1344 | 21 CFR Part 26 Mutual recognition of pharmaceutical good manufacturing practice reports, and certain medical device product evaluation reports: US and the EC |
| 1345 | 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
| 1346 | 21 CFR Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use |
| 1360 | Reflection Paper on Markers Used for Quantitative and Qualitative Anaysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products |
| 1387 | Current Practices in the Validation of Aseptic Processing - 2001 |
| 1388 | 2003/94/EC - Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use; Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products |
| 1389 | Introduction |
| 1396 | Applications for Parenteral Products in Plastic Immediate Containers |
| 1437 | PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance |
| 1438 | Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007 |
| 1441 | Part 11, Electronic Records, Electronic Signatures: Scope and Application |
| 1449 | GAMP Good Practice Guide Validation of Process Controls Systems |
| 1450 | Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process |
| 1451 | Drug Approval Application Process |
| 1462 | Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin |
| 1463 | Guide to Good Manufacturing Practice for Medicinal Products (PE 009-10) Introduction |
| 1464 | PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PI 008-3) Sept 2007 |
| 1465 | Site Master File for Source Plasma Establishments (PI 019-3) Sept 2007 |
| 1466 | Site Master File for Plasma Warehouses (PI 020-3) Sept 2007 |
| 1470 | Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions |
| 1475 | Acceptability of Standards from Alternative Compendia (BP/EP/JP) |
| 1476 | Draft Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility |
| 1477 | EC/1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Note: shall apply from 30 December 2008)(consolidated version : 2/7/2012). |
| 1478 | EC/658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 155, 15/6/2007 p. 10 - 19). |
| 1502 | The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) |
| 1503 | GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS |
| 1504 | Section 1 |
| 1505 | Section 2 |
| 1506 | Section 3 |
| 1508 | INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information |
| 1513 | Eudralex Volume 10 - Clinical Trials |
| 1537 | Note for Guidance on Quality of Modified Release Products: A. Oral Dosage Forms; B. and Transdermal Dosage Forms; Section I (Quality) |
| 1576 | WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principle |
| 1577 | Active pharmaceutical ingredients (bulk drug substances) |
| 1578 | Pharmaceutical excipients |
| 1579 | WHO Good Manufacturing paractices for Sterile pharmaceutical products |
| 1580 | Biological products |
| 1581 | Investigational pharmaceutical products for clinical trials in humans |
| 1582 | Herbal medicinal products |
| 1585 | STANDARD OPERATING PROCEDURE TEAM INSPECTIONS (PI 031-1) |
| 1597 | Guideline on Plastic Immediate Packaging Materials |
| 1647 | Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use" |
| 1650 | Q1E Evaluation of Stability Data |
| 1838 | 2002/98/EC - Directive 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 2003
setting standards of quality and safety for the collection, testing, processing, storage and distribution
of human blood and blood components and amending Directive 2001/83/EC |
| 1839 | 2003/63/EC - COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003
amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use |
| 1849 | Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) (August 2004) |
| 1850 | Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7) |
| 1851 | Guideline on the procedure for VAMF certification |
| 1852 | Guideline on the procedure for PMF certification |
| 1862 | NOTICE TO APPLICANTS Volume 6B
VETERINARY MEDICINAL PRODUCTS Presentation and content of the
dossier |
| 1865 | Bioanalytical Method Validation (Issued 5/2001, Posted 5/22/2001) |
| 1867 | Bioavailability and Bioequivalence Studies for orally administered drug products - General considerations (Issued 3/2003, Posted 3/19/2003) |
| 1869 | Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation |
| 1870 | Topical Dermatologic Corticosteroids, in vivo Bioequivalence |
| 1871 | Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posed 8/25/1997) |
| 1872 | Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlation (Issued 9/1997, Posted 9/26/1997) |
| 1873 | M4Q Implementation Working Group - Questions and Answers(R1) |
| 1874 | M4 Implementation Working Group - Questions and Answers (R3) |
| 1875 | M4: Organization of the CTD |
| 1877 | GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD
TRANSMISSIBLE INFECTIONS |
| 1884 | Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003) |
| 1885 | Metaproterenol Sulfate and Albuterol Metered Dose Inhalers in Vitro (Issued 6/27/1989, Posted 3/2/1998) |
| 1887 | Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs |
| 1888 | Statistical Approaches to Establishing Bioequivalence (Issued 2/2001; Posted 2/1/2001) |
| 1889 | Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Poste 8/31/2000) |
| 1890 | Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003) |
| 1892 | Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide |
| 1902 | Analytical Procedures and Methods Validation (Issued 8/2000, Posted 8/30(2000) |
| 1903 | Comparability Protocols - Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003) |
| 1904 | Drugs, Biologics, and Medical Devices Derived from Bioengineering Plants for Use in Humans and Animals (Posted 9/11/2003) |
| 1905 | Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Poted 1/28/2003) |
| 1906 | Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003) |
| 1907 | Interpreting Sameness of Monoclonal Antibody Products under the Orphan Drug Regulations (Issued 1/2004, Posted 1/6/2004) |
| 1908 | Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmacokinetics, Bioavailability, and Labeling Documentation (Issued 7/2002, Posted 8/20/2002) |
| 1935 | Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations |
| 1941 | APIC - List of Abbreviations & Acronyms |
| 1942 | APIC - Good manufacturing practices
for Active ingredient manufacturers, with EFPIA, 1996 |
| 1943 | APIC - Quality Management System for Active pharmaceutical Ingredient manufacturers - Integrating GMP into ISO 9001, December 1997 |
| 1944 | APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999 |
| 1945 | APIC - Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants - Policy, 1999 |
| 1946 | APIC - Good Manufacturing Practices
in Active Pharmaceutical Ingredients Development, 1999 |
| 1947 | APIC - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, guidance 2000 |
| 1948 | APIC - GMPs for APIs: “How to do” Document - Interpretation of the ICH Q7 Guide - Version 7 |
| 1949 | APIC - Computer validation Guide, December 2002 |
| 1950 | APIC CEFIC Auditing Guide |
| 1955 | APIC - Parametric Release document, December 2002 |
| 1986 | Botanical Drug Products |
| 1988 | Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
APRIL 1996 |
| 1989 | Development of new stereoisomeric drugs |
| 1990 | Drug Master Files for
Bulk Antibiotic Drug Substances |
| 1991 | Drug Master Files, Current DMF Information |
| 2002 | Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004) |
| 2012 | Corrigendum (Official Journal L 302, 20/11/2003 p. 40 DE). |
| 2015 | 2004/27/EC Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/4/2004 p. 34 - 57). |
| 2017 | 2003/94/EC - Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14/10/2003 p. 22 - 26). |
| 2018 | Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts |
| 2021 | COM/2003/839 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. [Update of the 1982 Commission Communication]. |
| 2022 | Corrigendum (Official Journal L 75, 4/4/1995 p. 29. |
| 2023 | EC/726/2004 - Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency |
| 2032 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs |
| 2042 | ANDAs: Pharmaceutical Solid Polymorphism |
| 2047 | Guidance for Industry Product Recalls, Including Removals and Corrections |
| 2059 | Annex 19: Reference and Retention Samples |
| 2060 | Q8(R2) Pharmaceutical Development |
| 2070 | APIC - Qualification of existing equipment (November 2004) |
| 2071 | APIC - Technical Change Control Guideline 2004 (October 2004) |
| 2072 | Recommendation on the Need for Revision of (CHMP) >Note for Guidance on Investigation of Bioavailability and Bioequivalence> CPMP/EWP/QWP/1401/98 |
| 2073 | The APIC Audit Programme, Version 3, August 2010 |
19-20 June 2013 